What Is ISO 9001?

What Is ISO 9001?

The ISO 9001 standard sets forth the actual requirements for an organization to comply to.  This is the "requirements standard" and as such, it has the conditions that must be fulfilled to get your certification/registration.

The 1987 and 1994 editions of ISO 9001 were focused on standardizing processes primarily through extensive documentation. Although the intent was to provide "customer satisfaction" and "continual improvement" those terms never actually appeared in the standard.

The 1994 edition, the ISO 9001 edition before the 2000 revision, had one main clause with 20 sub-clauses. Each of the sub-clauses focused on a specific type of operation in companies. For example, there was a clause (4.3) titled "Contract Review" that focused on customer order review.

Another one was a clause titled "Process Control" (4.9). However, it focused on production processes, not all processes. Each was considered a separate entity and was treated that way when documenting and implementing, as well as being audited.

The 2000 edition was completely reformatted and re-focused. This edition contains only five clauses. They are based of the processes most companies have. The new formatting is geared toward the interaction of the processes in companies. All processes in companies rely on each other for their input and output.

ISO 9001-2008 retains the intent and format of the 2000 revision. The changes in the 2008 revision are editorial in nature. See the 2008 changes.

The Process Approach

ISO 9001:2008 requires companies to identify the processes in their organization as well as the interaction of these processes in order to enhance customer satisfaction through continual improvement.

The process approach starts with customer requirements as the initial input and customer satisfaction and continual improvement as the output. The phrases "customer satisfaction" and "continual improvement" actually appear in this standard and requirements have been set for measuring and monitoring activities based on objective measurements.

The requirements are: (click on the clause title for more information)

Clause 4 - Quality management system

Clause 5 - Management responsibility

Clause 6 - Resource management

Clause 7 - Product realization

Clause 8 - Measurement, analysis and improvement

ISO 9002 and ISO 9003 Dumped

Another of the significant changes from previous editions is there is only one standard opposed to three. The 2000 revision of ISO 9001 includes everything from product design or development to servicing the product after the sale. ISO 9002 and ISO 9003 were no longer necessary as ISO 9001 incorporated a method for organizations to exclude some requirements from their certification scope.

Speaking of design and development, under the previous edition of the standard companies could simply choose not to include specific operations or processes in the scope of their quality management system and certification.

For example, if they didn’t want to include product design engineering, sometimes referred to as "wild cards" because of the lack of standardization between engineers, they chose certification to ISO 9002, which didn’t include design control. This is no longer possible.

You can only exclude a process by justifying that it doesn’t affect customer or regulatory requirements. That's tough to prove when you design and/or develop the product or service what customers buy.

This initially resulted in many companies not transitioning from the 1994 edition to the 2000 standard and therefore eventually losing their certification.

Additional Information On These Topics:

What are Quality Management Systems?

What is ISO 9000?

What is ISO 9001?

What is ISO 9004?

What is ISO 19011?

ISO 9000-2008 Changes

Online ISO 9000/9001 Overview Course

Auditor Training: Online

Auditor Training Courseware

Additional Information Resources